Multi-event October 2019 FDA Recall Drug by 8046255 Canada Inc. Dba Viatrexx
This Multi-event Class II drug recall was voluntarily initiated by 8046255 Canada Inc. Dba Viatrexx on October 15, 2019 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
D-0343-2020 D-0328-2020 D-0340-2020 D-0347-2020 D-0341-2020 D-0326-2020 D-0327-2020 D-0330-2020 D-0345-2020 D-0348-2020 D-0335-2020 D-0337-2020 D-0344-2020 D-0332-2020 D-0336-2020 D-0334-2020 D-0333-2020 D-0342-2020 D-0339-2020 D-0331-2020 D-0346-2020 D-0338-2020 D-0329-2020
Recall Number: D-0343-2020
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
10-15-2019
11-20-2019
8 vials
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
8046255 Canada Inc. DBA Viatrexx
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Distributed to physicians Nationwide throughout the United States and Puerto Rico.
12-10-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Viatrexx-Intra-Cell, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0280, NDC 73069-250-41.
Batch or Lot Expiration Information
Lot# Lot Numbers: 19-S00025, Exp. May: 2020
Recall Number: D-0328-2020
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
10-15-2019
11-20-2019
19 vials
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
8046255 Canada Inc. DBA Viatrexx
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Distributed to physicians Nationwide throughout the United States and Puerto Rico.
12-10-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Viatrexx-Ouch, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0500, NDC 73069-402-41.
Batch or Lot Expiration Information
Lot# Lot Numbers: 19-S00003, Exp. May: 2020
Recall Number: D-0340-2020
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
10-15-2019
11-20-2019
6 vials
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
8046255 Canada Inc. DBA Viatrexx
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Distributed to physicians Nationwide throughout the United States and Puerto Rico.
12-10-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Viatrexx-Arthros, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0030, NDC 73069-035-41.
Batch or Lot Expiration Information
Lot# Lot Numbers: 19-S00021, Exp. May: 2020
Recall Number: D-0347-2020
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
10-15-2019
11-20-2019
2 vials
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
8046255 Canada Inc. DBA Viatrexx
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Distributed to physicians Nationwide throughout the United States and Puerto Rico.
12-10-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Viatrexx-Male+, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0400, NDC 73069-320-41.
Batch or Lot Expiration Information
Lot# Lot Numbers: 19-S00022, Exp. May: 2020
Recall Number: D-0341-2020
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
10-15-2019
11-20-2019
18 vials
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
8046255 Canada Inc. DBA Viatrexx
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Distributed to physicians Nationwide throughout the United States and Puerto Rico.
12-10-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Viatrexx-Immunexx, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0270, NDC 73069-244-41.
Batch or Lot Expiration Information
Lot# Lot Numbers: 19-S00023, Exp. May: 2020
Recall Number: D-0326-2020
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
10-15-2019
11-20-2019
24 vials
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
8046255 Canada Inc. DBA Viatrexx
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Distributed to physicians Nationwide throughout the United States and Puerto Rico.
12-10-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Viatrexx-Connectissue, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0090, NDC 73069-100-41.
Batch or Lot Expiration Information
Lot# Lot Numbers: 19-S00001, Exp. May: 2020
Recall Number: D-0327-2020
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
10-15-2019
11-20-2019
61 vials
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
8046255 Canada Inc. DBA Viatrexx
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Distributed to physicians Nationwide throughout the United States and Puerto Rico.
12-10-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Viatrexx-MuSkel-Neural, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC4020, NDC 73069-347-41.
Batch or Lot Expiration Information
Lot# Lot Numbers: 19-S00002, Exp. May: 2020
Recall Number: D-0330-2020
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
10-15-2019
11-20-2019
4 vials
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
8046255 Canada Inc. DBA Viatrexx
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Distributed to physicians Nationwide throughout the United States and Puerto Rico.
12-10-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Viatrexx-Adipose, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0008, NDC 73069-024-41.
Batch or Lot Expiration Information
Lot# Lot Numbers: 19-S00005, Exp. May: 2020
Recall Number: D-0345-2020
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
10-15-2019
11-20-2019
3 vials
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
8046255 Canada Inc. DBA Viatrexx
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Distributed to physicians Nationwide throughout the United States and Puerto Rico.
12-10-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Viatrexx-Hair, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0251, NDC 73069-206-41.
Batch or Lot Expiration Information
Lot# Lot Numbers: 19-S00009, Exp. May: 2020
Recall Number: D-0348-2020
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
10-15-2019
11-20-2019
1 vial
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
8046255 Canada Inc. DBA Viatrexx
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Distributed to physicians Nationwide throughout the United States and Puerto Rico.
12-10-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Viatrexx-ANS/CNS, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0025, NDC 73069-039-41.
Batch or Lot Expiration Information
Lot# Lot Numbers: 19-S00027, Exp. May: 2020
Recall Number: D-0335-2020
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
10-15-2019
11-20-2019
22 vials
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
8046255 Canada Inc. DBA Viatrexx
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Distributed to physicians Nationwide throughout the United States and Puerto Rico.
12-10-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Viatrexx-Collagen, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0085, NDC 73069-095-41.
Batch or Lot Expiration Information
Lot# Lot Numbers: 19-S00014, Exp. May: 2020
Recall Number: D-0337-2020
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
10-15-2019
11-20-2019
3 vials
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
8046255 Canada Inc. DBA Viatrexx
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Distributed to physicians Nationwide throughout the United States and Puerto Rico.
12-10-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Viatrexx-Lymph 1, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0370, NDC 73069-310-41.
Batch or Lot Expiration Information
Lot# Lot Numbers: 19-S00017, Exp. May: 2020
Recall Number: D-0344-2020
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
10-15-2019
11-20-2019
13 vials
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
8046255 Canada Inc. DBA Viatrexx
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Distributed to physicians Nationwide throughout the United States and Puerto Rico.
12-10-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Viatrexx-Facial, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0184, NDC 73069-164-41.
Batch or Lot Expiration Information
Lot# Lot Numbers: 19-S00026, Exp. May: 2020
Recall Number: D-0332-2020
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
10-15-2019
11-20-2019
69 vials
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
8046255 Canada Inc. DBA Viatrexx
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Distributed to physicians Nationwide throughout the United States and Puerto Rico.
12-10-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Viatrexx-Articula, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0031, NDC 73069-037-41.
Batch or Lot Expiration Information
Lot# Lot Numbers: 19-S00008, Exp. May: 2020
Recall Number: D-0336-2020
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
10-15-2019
11-20-2019
42 vials
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
8046255 Canada Inc. DBA Viatrexx
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Distributed to physicians Nationwide throughout the United States and Puerto Rico.
12-10-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Viatrexx-Prolo, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0558, NDC 73069-443-41.
Batch or Lot Expiration Information
Lot# Lot Numbers: 19-S00016, Exp. May: 2020
Recall Number: D-0334-2020
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
10-15-2019
11-20-2019
54 vials
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
8046255 Canada Inc. DBA Viatrexx
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Distributed to physicians Nationwide throughout the United States and Puerto Rico.
12-10-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Viatrexx-Infla, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0279, NDC 73069-249-41.
Batch or Lot Expiration Information
Lot# Lot Numbers: 19-S00012, Exp. May: 2020
Recall Number: D-0333-2020
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
10-15-2019
11-20-2019
7 vials
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
8046255 Canada Inc. DBA Viatrexx
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Distributed to physicians Nationwide throughout the United States and Puerto Rico.
12-10-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Viatrexx-Neuro 3, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0463, NDC 73069-373-41.
Batch or Lot Expiration Information
Lot# Lot Numbers: 19-S00010, Exp. May: 2020
Recall Number: D-0342-2020
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
10-15-2019
11-20-2019
1 vial
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
8046255 Canada Inc. DBA Viatrexx
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Distributed to physicians Nationwide throughout the United States and Puerto Rico.
12-10-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Viatrexx-Relief +, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0615, NDC 73069-450-41.
Batch or Lot Expiration Information
Lot# Lot Numbers: 19-S00024, Exp. May: 2020
Recall Number: D-0339-2020
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
10-15-2019
11-20-2019
3 vials
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
8046255 Canada Inc. DBA Viatrexx
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Distributed to physicians Nationwide throughout the United States and Puerto Rico.
12-10-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Viatrexx-GI, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0211, NDC 73069-189-41.
Batch or Lot Expiration Information
Lot# Lot Numbers: 19-S00019, Exp. May: 2020
Recall Number: D-0331-2020
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
10-15-2019
11-20-2019
5 vials
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
8046255 Canada Inc. DBA Viatrexx
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Distributed to physicians Nationwide throughout the United States and Puerto Rico.
12-10-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Viatrexx-Systemic Detox, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0665, NDC 73069-500-41.
Batch or Lot Expiration Information
Lot# Lot Numbers: 19-S00007, Exp. May: 2020
Recall Number: D-0346-2020
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
10-15-2019
11-20-2019
13 vials
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
8046255 Canada Inc. DBA Viatrexx
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Distributed to physicians Nationwide throughout the United States and Puerto Rico.
12-10-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Viatrexx-Neuro, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0460, NDC 73069-375-41.
Batch or Lot Expiration Information
Lot# Lot Numbers: 19-S00020, Exp. May: 2020
Recall Number: D-0338-2020
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
10-15-2019
11-20-2019
7 vials
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
8046255 Canada Inc. DBA Viatrexx
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Distributed to physicians Nationwide throughout the United States and Puerto Rico.
12-10-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Viatrexx-Mesenchyme, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0092, NDC 73069-102-41.
Batch or Lot Expiration Information
Lot# Lot Numbers: 19-S00018, Exp. May: 2020
Recall Number: D-0329-2020
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
10-15-2019
11-20-2019
12 vials
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
8046255 Canada Inc. DBA Viatrexx
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Distributed to physicians Nationwide throughout the United States and Puerto Rico.
12-10-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Viatrexx-Ithurts, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0290, NDC 73069-270-41.
Batch or Lot Expiration Information
Lot# Lot Numbers: 19-S00004, Exp. May: 2020
